Daewoong Pharmaceutical announced that as a result of the phase 3 clinical trial of Fexuclu, a new drug for gastroesophageal reflux disease, 99.1% of patients with mucosal defects completely healed following 8 weeks of administration.
Daewoong Pharmaceutical (CEO Chang-jae Lee, Seung-ho Jeon) announced on the 25th that it had announced the results of the phase 3 clinical trial of Fexuclu Tablet at the conference of the Korean Chamber of Commerce and Industry held at the Grand Hotel in Switzerland for two days from the 18th. A total of 570 people from 23 countries participated in this conference, which was held both online and offline.
Professor Kim Kwang-ha of the Department of Gastroenterology at Pusan National University Hospital announced the results of the Phase 3 clinical trial of Fexuprazan, through a lecture titled ‘Fexuprazan, the new wave of GI treatment’.
Professor Kim Gwang-ha said, “According to the results of phase 3 fexuclu conducted at 25 hospitals in Korea, 99.1% of patients with mucosal defects completely healed following 8 weeks of administration of fexuclu, indicating a high cure rate for erosive esophagitis.” As it has the longest half-life of regarding 9 hours among the Proton Pump Inhibitor (PPI) as well as the Potassium-Competitive Acid Blocker (P-CAB), one tablet once a day provides excellent nocturnal acid secretion (nocturnal). Acid Breakthrough, NAB) improvement effect can be expected.”
Professor Kim said, “Unlike most PPI preparations taken before meals, Fexuclu can be taken without regard to meals, which can improve the patient’s convenience, and drug interactions with drugs that depend on the CYP2C19 metabolic pathway such as Clopidogrel occur. “The risk is low,” he added, “the effect of the drug may vary depending on race. Fexuclu showed consistent efficacy regardless of race in clinical trials conducted on Koreans, Japanese, and Caucasians.”
As a result of the clinical trial, it showed significant improvement compared to Esomeprazole in ‘heartburn’, a typical symptom of gastroesophageal reflux disease, and ‘chronic cough’, a typical symptom of gastroesophageal reflux disease. Professor Kim said that in the case of moderate to severe patients, the proportion of patients without heartburn on the third day of administration was 22.4%, which was three times higher than that of esomeprazole.
An official from Daewoong Pharmaceutical said, “The company is developing various additional indications for Fexuclu, including maintenance therapy following treatment for erosive gastroesophageal reflux disease and phase 3 for the prevention of ulcers caused by nonsteroidal anti-inflammatory drugs (NSAIDs). Through this, we plan to satisfy the diverse needs of patients.”
